Placental Transfusion and Cord Clamping

Not Applicable

Completed

• Conditions: Placental Transfusion
• Interventions: Procedure: Position at introitus level; Procedure: position at Maternal Abdomen

• Registration Number: NCT01497353
• Lead Sponsor: Fundacion para la Salud Materno Infantil

Brief Summary

To compare the evolution of the infant's weight before delayed cord clamping (2 minutes after birth) as an indirect measure of the volume of placental transfusion in a group of healthy and fullterm newborns, placed at the level of the introitus versus another group placed on the abdomen of the mother.

Detailed Description

No inferiority, Randomized controlled trial not blind, Multicenter. Informed consent will be obtained during pregnancy or admittance and previous to birth.

Hypothesis: Placing the infant on the maternal abdomen without cord clamping during the first 2 minutes after birth does not change significantly the transfusion volume as compared to infants whose cord is clamped after 2 minutes but who are placed at the level of the introitus

Term newborns by vaginal delivery and without complications will be included. Study subjects will be assigned to two groups, both with delayed clamping,according to a sequence of random numbers generated by computer. The assignment will be done through opaque, sealed, easy opening envelopes, opening the envelope at the moment the mother enters the delivery room. Both parents and obstetric group will be then informed about which group the infant will be assigned to.

In both groups: The newborn will be immediately placed on a scale, previously set at the level of the maternal introitus to record his/her weight.

Group 1: Clamping at level of introitus: The infant will be held by the neonatologist at introitus level,immediately after the initial weight Group 2: Clamping on Maternal Abdomen: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement.

In both groups:A plastic clamp will be put at approximately 1cm from the cutaneous insertion of the umbilical cord at 120 seconds after birth and then a new Weight will be obtained after clamping.

Weight differences will be evaluated when positioning the infant at the level of the introitus or on the maternal abdominal-thoracic level (at or over placental level).

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-22
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-17
• Last Update Posted: 2012-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Term newborns
• vigorous born by vaginal delivery
• informed consent Signed.

Exclusion Criteria

• History of Placenta previa,
• postpartum hemorrhage background,
• Multiple gestation.
• Background of IUGR prenatally diagnosed.
• Major congenital malformations diagnosed previous to delivery.
• Maternal diseases such as: eclampsia, Rh incompatibility, congestive cardiac failure.
• Extraction of blood sample for bank of umbilical cord stem cells.

Elimination criteria:

• Need for immediate assistance of the newborn,
• Birth weight less than 2500 g,
• Nuchal cord wrapped too tight,
• Major congenital malformations not diagnosed during prenatal period,
• Delivery surgically finished Short umbilical cord which might prevent placing the infant in the assigned place .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Position at introitus level	Position at introitus level	The newborn will be held by the neonatologist at the level of the introitus, the cord will be clamped at 2 minutes after birth. New weigh will be obtained after that.
Position at Maternal Abdomen	position at Maternal Abdomen	The newborn will be placed on the abdomen and of the mother immediately after the first weigh measurement. The cord will be clamped at 2 minutes after birth .

Primary Outcome Measures

Name	Time	Method
Compare infant's birth weight before delayed cord clamping as an indirect measure of the volume of placental transfusion in a group of healthy fullterm newborns placed at the level of the introitus versus at the the mother's abdomen.	inmediately after birth until 2 minutes after birth	Every elegible and randomiced newborn will be Immediately after birth placed on a scale at the level of the introitus, and the infant's weight will be recorded at 10± 2 sec.; Group 1: The infant will be held by the neonatologist at introitus level. The cord will be clamped at 120 seconds after birth.; Group 2: The newborn will be placed on the abdomen of the mother immediately after the first weight measurement. The cord will be clamped at 120 seconds after birth.; Both groups will be weigth after the cord clamping.

Secondary Outcome Measures

Name	Time	Method
To compare venous hematocrit and bilirubin values between the 2 groups.	36-48 hs	venous hematocrit and bilirubin will be taken together with the sample taken for the mandatory neonatal screening.

Trial Locations

Locations (3)

Sanatorio de la Trinidad Palermo; 🇦🇷 Buenos Aires, Caba, Argentina

Hospital Materno Infantil de San Isidro Dr. C. Gianantonio; 🇦🇷 San Isidro, Buenos Aires, Argentina

Instituto de Meternidad y ginecología Nuestra señora de las Mercedes; 🇦🇷 San Miguel de Tucumán, Tucumán, Argentina